MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS

Model Number VICM5_12.6

Device Problem No Apparent Adverse Event (3189)

Patient Problem Vitreous Floaters (1866)

Event Type  malfunction  

Event Description

The reporter indicated the surgeon implanted a 12.6mm vicm5_12.6 implantable collamer lens, -10.50 diopter, into the patients right eye (od) on (b)(6) 2022.The patient complained of vitreous floaters post-op and the lens remained implanted.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

H6 - work order search: no similar complaint was reported for units within the same lot.(b)(4).

Manufacturer Narrative

B5: the reporter indicated the cause of the event was patient-related factor and the device did not fail to perform as intended (pre-existing condition of floaters).The lens remained implanted and the eye is healthy.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17200362
• MDR Text Key: 318236104
• Report Number: 2023826-2023-02518
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542119191
• UDI-Public: 00841542119191
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: VICM5_12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/26/2023
• Supplement Dates Manufacturer Received: 07/07/2023
• Supplement Dates FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL SFC-45 - LOT # UNK.; FOAM TIP PLUNGER MODEL FTP - LOT # UNK.; INJECTOR MODEL AND LOT # UNK.
• Patient Sex: Male